*Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?*

Phase 4

Completed

• Conditions: pertussis; whooping cough; 10004018

• Registration Number: NL-OMON49737
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6750

Inclusion Criteria

1. 18 years or older , 2. Being pregnant , 3. Having an antenatal appointment
with a midwife or obstetrician in the 1st trimester of pregnancy , 4. Signed
informed consent , 5. Parents who are willing to adhere to the protocol and
perform all planned visits and, sample collections for themselves and their
newborn child (only relevant for the immunogenicity part

Exclusion Criteria

1. All women with one or more missing inclusion criteria, 2. History of having
received a pertussis containing vaccination in the past 2 years. , 3. History
of having had pertussis disease in the past 5 years., 4. Known or suspected
serious underlying condition that can interfere with the results, of the study
such as but not limited to cancer, autoimmune disease, immunodeficiency,
seizure disorder or significant psychiatric illness., 5. Receipt of any
high-dose (>=20 mg of prednisone daily or equivalent) daily corticosteroids
within 2 weeks of study entry (inhaled or other local steroids are acceptable)
with exception of corticosteroids to enhance maturation of fetal lungs in case
of imminent early delivery., 6. Receipt of other immune modulating medication,
for instance biologicals., 7. Receipt of blood products or immunoglobulins,
within three months of study entry, (Rhesus negative women who receive
anti-rhesus (D)- immunoglobulin will not be, excluded from the study)., 8.
Presence of bleeding disorder., 9. Having experienced a previous severe adverse
reaction to any vaccine., 10. Receipt of any vaccine(s) within 2 weeks of study
vaccine (except influenza, vaccine which may be given concomitantly).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Serum IgG antibody levels against vaccine antigen PT in preterm and term<br /><br>infants at 2 months of age, before start of infant vaccination.</p><br>